Last updated on emc: 22 Nov 2019

What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet.
The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on 0800 198 5000.
The product code(s) for this leaflet is: PL36633/0001.

Octasa 800 mg MR Tablets

Package leaflet: Information for the user

Octasa 800 mg Modified Release Tablets

Active substance: mesalazine

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Octasa is and what it is used for
2. What you need to know before you take Octasa
3. How to take Octasa
4. Possible side-effects
5. How to store Octasa
6. Contents of the pack and other information

1. What Octasa is and what it is used for

Octasa contains the active substance mesalazine. This is an anti-inflammatory medicine used to treat ulcerative colitis and Crohn’s ileo-colitis.

Octasa is used:

to treat and prevent further episodes of ulcerative colitis

to prevent further episodes of Crohn’s ileo-colitis once the disease has been brought under control.

Ulcerative colitis is a disease of the large bowel (colon) or back passage (rectum), in which the lining of the bowel becomes inflamed (red and swollen).

Crohn’s ileo-colitis is a disease that affects the small bowel (terminal ileum) and the large bowel (colon) in which the lining of the bowel becomes inflamed. This can lead to ulcers, abscesses and narrowing (strictures) in the bowel.

Octasa acts locally at the site of inflammation (colon, rectum and terminal ileum) to reduce this inflammation.

2. What you need to know before you take Octasa

Do not take Octasa

If you are allergic to mesalazine or any of the other ingredients of this medication (listed in section 6)

If you are allergic to salicylates (e. g. aspirin)

If you have severe kidney problems

If you have severe liver problems

Warnings and precautions

Talk to your doctor before taking Octasa if you have any medical conditions or illnesses, particularly if you have:

ever had any problems with your kidneys. This is especially important if you are elderly.

any lung problems, e. g. asthma.

suffered an allergy to sulfasalazine in the past.

ever had allergic reactions of your heart such as inflammation of the heart muscle or heart sac. If you have had previous suspected mesalazine-induced allergic reactions of your heart, then Octasa must not be taken. Octasa can be taken with care if you have had a previous allergic reaction of the heart not caused by mesalazine.

If you have an ulcer of the stomach or intestine, you may take Octasa with care

Kidney stones may develop with use of Octasa. Symptoms may include pain in sides of abdomen and blood in urine. Take care to drink sufficient amount of liquid during treatment with Octasa.

Test for your liver, kidney and blood

Before and while you are taking Octasa, your doctor may want to monitor you from time to time, to check that your liver, kidneys, blood and lungs are all right.

There have been a few reports of intact tablets in the stool. What appear to be intact tablets may sometimes be the remains of the tablet coating. If you often observe tablets or tablet shells in the stool, you should consult your doctor.

Children and adolescents

Octasa is only recommended for use in children 6 years and older.

Other medicines and Octasa

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines such as:

drugs affecting the immune system (e. g. azathioprine, or 6-mercaptopurine or thioguanine)

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Octasa should be taken before meals. This medication must be swallowed whole preferably with some liquid. Do not chew, crush or break the tablets before swallowing them.

Whilst taking this medication ensure you drink adequate fluids to remain well hydrated, especially after severe or prolonged episodes of vomiting and/or diarrhoea, high fever or heavy sweating. This is to avoid problems with your kidney.

3 tablets may be taken once daily or in divided doses (as advised by your doctor).

Above 3 tablets a day should be taken in divided doses.

To prevent ulcerative colitis or Crohn’s ileo-colitis your daily dose is 2 to 3 tablets once daily or in divided doses. Do not take more than 6 tablets per day, and do not take more than 3 tablets together at the same time.

Use in children and adolescents

Octasa is only recommended for use in children 6 years and older.

The daily dose depends on the child’s weight.

To treat acute phases of ulcerative colitis:
20-30 kg weight: one tablet per day.
30-40 kg weight: one to two tablets per day in divided doses.
Above 40 kg weight: two to three tablets per day in divided doses.
The total dose should not exceed 4 g/day.

To prevent ulcerative colitis or Crohn’s ileo-colitis:
30-40 kg weight: one tablet per day.
Above 40 kg weight: one to two tablets per day in divided doses.
The total dose should not exceed 2 g/day.

It is generally recommended that half the adult dose may be given to children up to 40 kg weight; and the normal adult dose to those above 40 kg.

If you take more Octasa than you should

You should not take a higher dose than your doctor has prescribed for you. Contact your nearest hospital casualty department or a doctor for advice if you or anyone else has swallowed too many tablets or if you think a child has swallowed any. Take this leaflet, and any tablets that you still have to show the doctor.

If you forget to take Octasa

If you forget to take a dose at the right time, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.

If you stop taking Octasa

Do not stop taking Octasa without talking to your doctor first even if you feel better.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side-effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Organ specific side effects affecting the heart, lungs, liver, kidneys, pancreas, skin and subcutaneous tissue have been reported.

Stop taking the medicine and seek urgent medical advice immediately if you experience any of the following:

inflammation of the membranes of the pleural cavity surrounding the lungs (pleurisy)

intolerance to mesalazine sometimes with worsening symptoms of underlying disease

kidney stones and associated kidney pain (see also section 2)

weight loss

laboratory test results out of normal range

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report any side effects directly via the Yellow Card Scheme online at www.mhra.gov.uk/yellowcard or via the free Yellow Card app. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Octasa

Keep out of the reach and sight of children.

Do not store above 25 °C.

Keep the tablets in the original package to protect them from moisture.

Do not use this medicine after the expiry date which is stated on the outer packaging. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.